In medical science, the use of injection equipment has gone well beyond the relatively simple needle and syringe as usually thought of in injection of material into a patient or in the sampling of body fluids taken directly from the patient. Intravenous dosage and transfusion along with accurate and intermittent control of the flow of medication solutions and mixes of whole blood with medicaments and diluents has extended beyond the body, directly, and extends into reliance upon apparatus for achieving the selected mixing, dilution, treatment and manipulation of body fluids and even their return and reintroduction to the body of the patient. This has caused a proliferation of exotic equipment beyond the simplistic use of mere tubing to a source or from a source to a reservoir. In a sense the apparatus becomes an extension of the body of the patient to achieve central access to the body fluids for analysis modification and recirculation. This is especially true of blood. Many manufacturers of intravenous sets, in view of the desired sterile aspects of such apparatus, have developed tubing, tubing connectors, and injection apparatus at the connectors for sterile entry of the cannula or needle in gaining access to an intravenous fluid en route to or from the body of a patient and to which a variety of the connectors are useful at pre-located Y-Sites, T-Sites, Manifold Sites, with plural entries possible at the same point in a flow line to or from the patient.
Collaterally, the body fluids themselves contain contaminants which threaten the health and even life of doctors, technicians, and nurses using or encountering them at points where serious contact with the fluids may occur. The most difficult problem is that a very sharp needle is present at the injection site or point of use of the intermediate connector and shielding at that point is desireable to protect both the patient and medical personnel. A wide spectrum of shielding proposals have offered specific structures to match the particular manufactured (septum) entry and removal sites and without serious regard to interchangeability or adaptability for use with sites of different style and manufacture. The present structure seeks to achieve three principal objectives (a) relative universality (b) shielding of the needle and (c) retention means fixing the needle to other connector and site elements or apparatus against chance of accidental disconnection at the injection or access site.
Typical of prior art structures are the devices shown in U.S. Pat. No. 4,998,925 of Habib Al-Soufi et al shows a cylindrical sleeve-like extension shield jacketing the extending needle of a syringe and an extended sleeve to slidably cover selected injection caps, sites (septums) or luers as connected to tubing or apparatus pieces. The Al Sioufi device shows a form of sheathed connector with the needle mounted in the connector and the needle which, on one end of the needle axis, projects into the sleeve or sheath and on the other end is open into a luer lock. The tubular sheath portion includes a J-slot which bridges one of the extension legs of a Y-connector and allows the rotation of the shielded connector to secure the located shielded connector to a Y connector or fitting.
These various connectors and plural or manifold connector shapes create a problem since special fitting structures were required as the Y-Connectors vary from taper fits, keyed fits and special locks and caps at each nipple, or access point, to facilitate the selected sterile entry to the fluid and extraction of fluid, where desired.
The present invention demonstrates an ability to accommodate plural forms of connectors while providing a unique safety shield for the needle tip and universal tether means to secure the connection against chance loss while presenting rectilinear surfaces in prevention of loss of manual and tactile control by the personnel using the medical plural site devices either at the patient or remote from the patient being served. The intermediate connectors of the present invention are useable with a wide range of injection apparatus and tubular fluid conducting equipment as found in almost any particular laboratory or hospital for intravenous usage while maintaining acceptable structure accommodating sterile procedures and in shielded protection of patients and technical or professional personnel.
In addition, the presently described structure extends to technicians a visual control access over the scarf or needle through the wall of the protective shield while including a resilient and flexible strap means selectively in support relation to adjacent connected apparatus, patients, or dispensing attachments against chance dislodgement. This is achieved, partly by a shield wall extension from one of the planar walls, of the rectilinear sheath to serve as a guard for the needle and the extended wall enhances easy access for selected adjustable fastening means. The protruding planar shield provides additional tactile control.
Finally, the unit of the present invention provides a secured needle or cannula for establishing flow communication between at least two sites in an in-line relation and both selectively accommodating flow to and through the connection and for body fluids, chemicals, medicaments, food supplements, blood and blood fractions.
In general, the device of the present invention is an intermediate connector for use with conventional tubing fittings in which sterile techniques and apparatus are utilized in a plurality of medical and scientific flow relationships. Most notable are procedures in which blood or other body fluid is withdrawn from a patient through tubing that extends the flow from the body and then directs the flow for treatment or analysis and may return the fluid to the body in improved or treated condition to the patient. In the interval of removal, medicaments, additives and treatment or analysis is accomplished. Substantially the same apparatus may introduce transfused fluids or fluid fractions to the patient. This involves routines and protocol to assure protection from contamination of both patient and professional persons administering the procedures. In a typical use environment, the apparatus of many styles, manufacture sizes and shapes are found serving as fittings for the tubing. This is especially so where there must be an introduction or withdrawal of material to and from the flow line. The storage vessels for additives such as plasma sacks, whole blood containers and saline bottles and vacuum chamber tubes are usually fitted with penetrable self sealing entries but there always remains the problem of tapping the patient or the containers and controllably merging the flow of these fluids and then returning the enhanced or treated fluids to the body of the patient. This requires penetration of the seal at the entry to the patient or at entry to the container and from the container to the flow lines. Simplistically, the flow through the seals is by bolus injection via hypodermic syringes. The cannula of the syringe was driven through the rubber-like seal or septum site and additives introduced to the blood or the blood might be selectively withdrawn into the syringe.
Tubing-sets (for example IV-sets) flow the blood or fluids from the veins into the sterile tubing and the body fluid courses through the tubing to and through treatment stations such as found at injection sites and provided by Y-fittings capped with rubber penetrating seals at injection or withdrawal sites and which allow selected sterile penetration by cannula and the selected insertion of additives or selected withdrawal of fluids from the same ports as for analytical purposes. Valving and by-passes are utilized for flow control.
The emphasis on the design of prior art connectors is really an extension of the bolus utilization by syringe at junctures in the flow lines, at the points of receiving flow and at the points of juncturing two or more flowing fractions. In the present invention, the cannula plays a different role than as an intermittent injection fount. The thrust toward sterility involved covers or guards over the needles until the time of use. The many different styles of shielding of the user from the needle tips or scarfs are well known as in the U.S. Pat. No. of Bennett 4,419,098 (tubular closed ended tube cover for the needles or cannula); in the disclosures of U.S. Pat. No. 4,998,925 to Habib Al-Soufi shielding the needle by means of an adapter and by a connector achieving almost complete coverage of an extended cannula while aligning the cannula for seal or septum caps for cannula penetration into the flow line. The structures of Ogle II in U.S. Pat. Nos. 4,834,716 and Re 33,617 provide a cylindrical sheath with an arched cutout permitting needle access to a cap seal of a fitting without the extension of the cannula beyond the protected limits in at least two manners of use (1) where the cannula is carried by a syringe and the syringe penetrates the connector body and (2) where the cannula is embedded in the terminal insert in the body and insertion is provided with a cylindrical receiving entry for a septum access to a tubing flow line.
Vincent L. Vaillancourt U.S. Pat. No. 4,511,359 provides a two piece telescoping combination of a needle carrying cap and a male septum structure penetrable by the needle on its axis and lock tabs connecting the two upon axial connection.
George A. Lopez U.S. Pat. No. 4,752,292 provides two elongate connector elements one preventing access except by axial telescoping access in which a tubular septum ended conduit, upon axial insertion, impinges upon an axially extended cannula. A click lock external of a first tubular element and impinging on a second tubular element establishes when the septum seal is penetrated. Release is by releasing the click lock and separating the outer tubular element from the inner tubular element by axial straight line pull.
Jean M. Bonaldo in U.S. Pat. No. 4,950,260 utilizes a two part connector structure in which a cannula projects through and into a tubular housing and the housing includes an integrally hinged cover element. The second part of the connector is elongate and friction insertable into the housing with a septum cap on the tip of the inserted element arranged for receiving the scarf of the cannula in providing flow through the second element. The second element includes a latch closed upon folding down the hinged cover. Alignment is assured by registry with the flat bottoms and by the cover receiver recesses.
Charles B. Fields in U.S. Pat. No. 5,088,984 extends a cannula carrying member through a male luer threaded lock covered at its one end by a septum seal and at its other end equipped with a one way valve element with separate sleeve closing on a valve element, a six piece construction.